CN101534784B - Catheter system - Google Patents

Catheter system Download PDF

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Publication number
CN101534784B
CN101534784B CN2007800388513A CN200780038851A CN101534784B CN 101534784 B CN101534784 B CN 101534784B CN 2007800388513 A CN2007800388513 A CN 2007800388513A CN 200780038851 A CN200780038851 A CN 200780038851A CN 101534784 B CN101534784 B CN 101534784B
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China
Prior art keywords
probe
pipe
described pipe
stomach
conduit according
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CN2007800388513A
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CN101534784A (en
Inventor
莱因霍尔德·沃尔肯斯特费尔
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Nutricia GmbH
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Pfrimmer Nutricia GmbH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0003—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth
    • A61J15/0007—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth inserted by using a guide-wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/0069—Tubes feeding directly to the intestines, e.g. to the jejunum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/008—Sensor means, e.g. for sensing reflux, acidity or pressure
    • A61J15/0088—Sensor means, e.g. for sensing reflux, acidity or pressure for sensing parameters related to the device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means
    • A61J2205/30—Printed labels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0062—Catheters; Hollow probes characterised by structural features having features to improve the sliding of one part within another by using lubricants or surfaces with low friction

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Otolaryngology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • External Artificial Organs (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention provides a catheter system comprising a stomach probe for gastric decompression or drainage of stomach fluids, and a jejunal probe for nutriment supply during enteral feeding. The stomach probe comprises a drainage tube to be inserted into the stomach of a patient, the drainage tube having proximal and distal ends and defining a lumen for receiving and for guiding insertion of the jejunal probe into the small intestine of the patient. The jejunal probe comprises a feeding tube to be inserted into the small intestine of a patient and defines a lumen for conveying liquid nutriment from an inlet at a proximal end thereof to one or more outlet openings formed at a distal end region of the feeding tube. The jejunal probe is sized and adapted to be received within the lumen of the stomach probe for guided insertion to the small intestine. The catheter system further comprises support means for supporting the jejunal probe within the lumen of the stomach probe such that the feeding tube maintains a spaced relation to an inner wall surface of the lumen of the drainage tube. The support means is typically provided over a longitudinal extent of the catheter system and comprises at least one projection which projects between an inner wall of the lumen of the drainage tube and an outer wall of the feeding tube received therein. The support means may be provided on either the stomach probe or on the jejunal probe. The invention thus also concerns a stomach probe and a jejunal probe as such.

Description

Conduit system
Technical field
The present invention relates to the conduit system for the harmonization of the stomach small intestinal that is configured in patient.Especially, the present invention relates to provides the conduit that is communicated with patient's stomach fluid for stomach decompression or stomach fluid expulsion, and the nutrition supply that is related to during the intestinal keeping provides the conduit that is communicated with patient's small intestinal fluid.The present invention also relates to make the method for these conduits.
The conduit that is used for being configured in the above-mentioned type of patient's stomach or small intestinal also is called " probe ", will be at whole this term of middle use that the following describes.About this point, be designed for configuration and will be called the stomach probe herein for the conduit of stomach decompression or discharging under one's belt.Similarly, be designed for the conduit (for example being used at the nutrition supply of intestinal between the trophophase) that is configured in the small intestinal and will be called jejunum probe (jejunal probe is named by jejunum, the top of the small intestinal that probe inserts) or nutritional probe.Importantly, the present invention not only relates to independent stomach probe and jejunum probe, but also relates to the conduit system that comprises the stomach probe of being combined with the jejunum probe.
Background technology
Provide the conduit that is communicated with patient's small intestinal fluid typically to be used between postoperative convalescent period, supplying with nutrition to patient.By the skin passage, namely by stomach wall, can be inserted into described conduit in the small intestinal, or replacedly be inserted by nose.If suitably disposed described intestinal nutrition conduit, so so long it remain on the appropriate location be used for reaching 6 or 7 weeks supply with nutrition to patient.Therefore, the intestinal nutrition of this sample loading mode by conduit is not only than the easier control of intravenous nutrition supply, and quite cheap.
Typically, be inserted into jejunum via the stomach probe of previous configuration being used for the nose of transportation nutrition to small intestinal-intestinal conduit.The stomach probe is designed to extend in patient's the stomach, and limits the inner chamber (lumen) that inserts by its guiding jejunum probe.Therefore, the stomach probe has the diameter larger than jejunum probe, even when the jejunum probe extends through it, the inner chamber of described stomach probe typically forms enough greatly to limit nutritional probe space on every side, for supplying with to patient between the trophophase from described gastric emptying or discharge stomach fluid by described nutritional probe.
Typically, the stomach probe has the length in about 1000mm to 1200mm scope, but nutritional probe usually more longer (for example 1600mm to 2000mm) enters the small intestinal so that they expose and extend beyond the stomach probe from small intestinal.When the inner chamber by the stomach probe inserted, the outer surface of nutritional probe typically contacted in the major part of their common length with the inner surface of the inner chamber of stomach probe.This has a lot of shortcomings, comprises that frictional resistance can hinder nutritional probe and place.
In this, what can understand is, places nutritional probe by the stomach probe and comprises soft, conduit flexible, minor diameter the chamber by nose, throat and esophagus of sliding along convoluted path.Consider the character of soft flexibility of described nutritional probe and the very little overall diameter that only has several millimeters, be appreciated that the frictional resistance between the inner surface of the inner chamber in the outer surface stomach function regulating probe of nutritional probe can make the insertion process complicated.In order to play the effect of help, often adopt seal wire (guidewire) in this.In addition, because the stomach probe typically is provided with the opening of side direction in its distal end regions, be used for realizing in intestinal nutrition program decompression and/or the drainage of stomach, contact between the inner surface of nutritional probe stomach function regulating probe bores also can partly be blocked described side direction porus excretorius, thereby causes the performance of stomach probe to be lower than optimum level.
During placing the intestinal nutritional probe, usually use endoscope to monitor that described probe enters into the process of small intestinal.Described endoscope illuminates the position in the patient body, and produces the video image of probe when probe advances towards the target location.Afterwards, insert the process that the medical professional of described probe can observe at video-frequency monitor probe.Yet the problem of this technology is under the illumination that is provided by many endoscopes, is difficult to observe known jejunum probe.
In addition, because small intestinal is the dynamic environment that stands the impact of vermicular movement and his/her health of moving patients, if placed the jejunum probe, guarantee that it is very important remaining on the position of expectation to the jejunum probe.
In view of above-mentioned consideration, the present invention relates to be provided for being placed on patient's stomach and/or the conduit in the small intestinal and conduit system, it is used for providing the mutual operability of improvement between stomach probe and nutritional probe.The invention still further relates in the visuality that the jejunum probe of improvement is provided with the endoscope viewing duration.In addition, the present invention aims to provide a kind of conduit, in case can remain on its locational larger ability when it has in the small intestinal of being placed on.
Summary of the invention
According to an aspect of the present invention, the invention provides a kind of conduit system, comprising:
Be used for the stomach probe of stomach decompression or stomach fluid drainage, comprise the delivery pipe in the stomach that is inserted into patient, described delivery pipe has near-end and far-end, and defines for receiving and guiding the jejunum probe to be inserted into the inner chamber of patient's small intestinal; With
Be used for the jejunum probe at the nutrition supply of intestinal between the trophophase, comprise the nutritive canal in the small intestinal that is inserted into patient, described nutritive canal defines inner chamber, for the one or more exit openings that form to the distal end regions in nutritive canal from the import transport liquid nutrition in its proximal end, described jejunum probe is dimensioned and is fit to be accommodated in the inner chamber of stomach probe, is used for being directed being inserted into small intestinal;
Wherein, described conduit system comprises for the bracing or strutting arrangement that the jejunum probe is supported on the inner chamber of stomach probe, so that the spaced relationship of the inner wall surface of the inner chamber of described nutritive canal maintenance and delivery pipe.
Therefore, described bracing or strutting arrangement is fit to remain on gap or the spacing between the inner wall surface of inner chamber of described nutritive canal and described delivery pipe, preferably on sizable length of the inner chamber of described stomach probe, more preferably on its whole length.Therefore, advantageously, described bracing or strutting arrangement is fit to support by this way described jejunum probe, is held so that be communicated with around the circumference range of described nutritive canal at the near-end of described delivery pipe and the fluid between the far-end, preferably on the whole length of stomach probe bores.Described bracing or strutting arrangement can and be contained between the outer wall of described nutritive canal wherein along the inwall of the inner chamber that vertically is arranged in described delivery pipe of described conduit system.In addition, described bracing or strutting arrangement preferably be fit to allow the relative motion between described nutritive canal and described delivery pipe, thereby is beneficial to the insertion of described jejunum probe and withdraws from.In this, described bracing or strutting arrangement preferably is fit to be provided at the low friction between described nutritive canal and the described delivery pipe or the friction that reduces.
In a preferred form of the present invention, described bracing or strutting arrangement is set up on the described stomach probe and comprises that at least one is outstanding, described outstanding wall from described delivery pipe inwardly is projected into the inner chamber of described stomach probe, so that the support member that described outstanding suitable formation contacts with the outer surface of jejunum probe when the jejunum probe is accommodated in the described inner chamber.
In interchangeable form of the present invention, yet described bracing or strutting arrangement can be arranged on the described jejunum probe.In this form, described bracing or strutting arrangement comprises that at least one is outstanding, and described outstanding wall from described nutritive canal is outwards outstanding so that when nutrition is accommodated in wherein the described outstanding support member that formation contacts with the inwall of the inner chamber of stomach probe that is fit to.
In each situation, in order to be minimized in the friction that produces when described jejunum probe is inserted through the inner chamber of described stomach probe, described at least one outstanding stayed surface is preferably become with respect to ninor feature.Therefore, described at least one outstanding preferably have a cross section that diminishes gradually towards described outstanding described stayed surface from the base regions of the wall of contiguous described pipe.For example, described outstanding cross section can be decreased to described stayed surface equably gradually from described base regions, and it can have the stayed surface of a circle.Replacedly, depend on the circumstances, described at least one outstanding cross section can have the form (for example semicircle) of whole circle, thereby presents the stayed surface for the bending that contacts with described jejunum probe or described stomach line probe.
In a preferred form of the present invention, described conduit system comprises a plurality of so outstanding, support member of each outstanding formation is used for keeping described nutritive canal and described delivery pipe relation at interval when described jejunum probe is accommodated in described stomach probe.Preferably, described giving prominence to roughly arranged respectively or is distributed in described delivery pipe or the nutritive canal along described longitudinal direction and circumferencial direction equably.Therefore; describedly outstanding be fit to guarantee or be limited to minimum interval or gap between described nutritive canal and the described delivery pipe, but described outstanding typically being dimensioned with in described " space (play) " or the gap (for example when described nutritive canal medially is arranged in the described delivery pipe) that is provided in the radial direction the specified quantitative between described two pipes.Therefore, in use, can change length along described delivery pipe in actual interval or gap between described two pipes on the specified point.In the time of on being arranged on the outer surface of described nutritive canal, on the described longitudinal extent of giving prominence in the inner chamber that preferably only is arranged on the described stomach probe of being accommodated in of described nutritive canal.On the other hand, in the time of on being arranged on described stomach probe, described giving prominence to typically only is arranged in the inner chamber of described delivery pipe.
According to a further aspect in the invention, therefore, the invention provides a kind ofly provides the conduit that is communicated with patient's stomach fluid for stomach decompression or stomach fluid drainage, described conduit comprises: be inserted into the pipe in patient's the stomach, described pipe has near-end and far-end, and defines for receiving and guiding probe to be inserted into the inner chamber of patient's small intestinal.Described pipe comprises from the wall of described pipe and is projected into bracing or strutting arrangement the described inner chamber, forms the support member that contacts with the outer surface of described probe when being accommodated in the described inner chamber at probe.Therefore, described bracing or strutting arrangement comprises that at least one is outstanding, and described outstanding wall from described pipe inwardly is projected into the described inner chamber.In this, described giving prominence to has the stayed surface that contacts with the outer surface of described probe, and described stayed surface preferably is arranged on the described outstanding inner most zone radially.Thereby the described outstanding support member that contacts with the outer surface of described probe that is fit to form when described probe is accommodated in the described inner chamber.
In order to be minimized in the friction that produces when described probe is inserted through described inner chamber, described outstanding stayed surface is preferably become with respect to ninor feature.The described outstanding cross section that preferably has, described cross section diminishes towards described stayed surface gradually from the base regions of the wall of contiguous described pipe.For example, described outstanding cross section can be decreased to described stayed surface equably gradually from described base regions.Replacedly, it can have crooked form (for example hemispherical).
In a preferred form of the present invention, describedly outstanding be elongated and extend with the form of rib along the wall of described pipe.Described rib can along the circumferencial direction of the longitudinal direction of described pipe or described pipe or on longitudinal direction and circumferencial direction (for example spiral helicine) extend.Therefore, circular tip or the ridge of stayed surface that described rib shape is outstanding, it is effectively so that only carry out line with the outer surface of described probe and contact.
In a preferred form of the present invention, described bracing or strutting arrangement comprises a plurality of outstanding from the wall of described pipe, each is outstanding be formed for be contained in described inner chamber in the support member that contacts of the outer surface of described probe.Described giving prominence to preferably roughly arranges on the wall of described pipe equably along described longitudinal direction and circumferencial direction.
According to another aspect of the present invention, the invention provides a kind of method of making above-mentioned conduit, may further comprise the steps:
Be provided for forming the extrusion die of pipe, described extrusion die is defined for the chamber of the wall that forms pipe and at least one depression that is communicated with the chamber that forms wall, and described at least one depression radially extends internally from the chamber of described formation wall; With
Squeeze out polymeric plastics material by described extrusion die, to form the pipe that limits inner chamber, the polymeric plastics material that squeezes out by each described depression thus forms elongated rib, described rib radially extends internally from the wall of described pipe and enters into described inner chamber, and longitudinally extends along the length of the described pipe that squeezes out.
In a preferred form of the present invention, described method further is included in the step of the described extrusion die of rotation during the described pressing steps, so that each rib has distortion on the longitudinal extent of described pipe or the form of spiral.Described extrusion die can be arranged in extruding jet nozzle, comprises the described extruding jet nozzle of rotation so that rotate the step of described extrusion die.
According on the other hand, the invention provides conduit system, comprising:
The stomach probe that is consisted of by above-mentioned conduit; With
Be used for the jejunum probe at the nutrition supply of intestinal between the trophophase, comprise the nutritive canal in the small intestinal that is inserted into patient, described nutritive canal limits inner chamber, for the one or more exit openings that form to the distal end regions in described nutritive canal from the import transport liquid nutrition in its proximal end, described jejunum probe is dimensioned and is fit to be accommodated in the described inner chamber of conduit, is used for being guided insertion to described small intestinal.
According to interchangeable aspect of the present invention, the invention provides a kind of for the conduit that is communicated with patient's small intestinal fluid is provided at the nutrition supply of intestinal between the trophophase.Described conduit comprises the pipe that is used for being inserted into patient's small intestinal by the stomach probe, and described pipe defines inner chamber, is used for the one or more exit openings that form to the distal end regions at pipe from the import transport liquid nutrition in the proximal end of pipe.In this aspect of the invention, described nutritive canal comprises from the outside outstanding bracing or strutting arrangement of the wall of described pipe, forms the support member that contacts with the inner surface of inner chamber in the stomach probe when being accommodated in the described stomach probe at described conduit.
Therefore, interchangeable aspect according to the present invention, described bracing or strutting arrangement comprises that at least one is outstanding, described outstanding wall from described nutritive canal is outwards outstanding and have a stayed surface that contacts for the inner surface with described stomach probe bores.Described at least one outstanding can be formed elongated as previously described rib, or as protuberance or knot with crooked or circular profile, so that it is less to be used for the stayed surface that contacts with described stomach probe bores.In this aspect of the invention, described bracing or strutting arrangement preferably includes a plurality of outstanding again, described outstanding being distributed on the circumference and/or longitudinal extent of described pipe.Give prominence to by forming as the described of the elongated rib of outwards giving prominence to from described nutrient canal of intestine, so that described pipe (it is typically very thin) some is hard, this help avoid during by the insertion of described stomach probe and be placed in the patient body during the kinking of not expecting of pipe.
According on the other hand, the invention provides conduit, preferably, provide as the conduit of the type that is communicated with patient's small intestinal fluid is provided at the nutrition supply of intestinal between the trophophase.Therefore, described conduit comprises the pipe in the small intestinal that preferably is suitable for being inserted into patient, described pipe limits inner chamber, is used for the one or more exit openings that form to the distal end regions at described pipe from the import transport liquid nutrition in the proximal end of described pipe.In addition, the outer surface of the larger proportion of described pipe is fit to reflection and has the visible light that is less than or equal to the 550nm wavelength, and does not basically reflect the visible light that has greater than the 550nm wavelength.
In this, wherein, it is 30% of external surface area at least that the foreign range of the larger proportion of described pipe is considered to usually.Preferably, the outer surface of the larger proportion of described pipe is greater than 40% of the external surface area of described pipe, more preferably greater than 60% of external surface area, most preferably greater than 80% of the external surface area of described pipe.In fact, the whole foreign range of described pipe can be provided with above-mentioned optical property.
In a preferred form of the present invention, the outer surface of described pipe is fit to the visible light that reflection has the wavelength in about 420nm to 520nm scope, more preferably in 440nm to 500nm scope, and absorbs the visible light that has greater than the 500nm wavelength.
Surprisingly, have been found that when conduit provides above-mentioned optical property that conduit (these conduits that for example are used for intestinal nutrition) is more visible significantly using under the endoscope illumination observation.Especially, in blue light range and to a certain extent the color treatments of the pipe of same visible spectrum in green range so that in the endoscopy program conduit be easy to more significantly identification and location.This means that described medical professional can more easily determine current position and the orientation of described probe, thereby simplified the insertion program.
In a preferred form of the present invention, the optical property of the outer surface of described pipe is to be provided by the pigment or the dyestuff that are fit in described tubing.
Therefore, can describe in another way, the invention provides as the conduit that is communicated with patient's small intestinal fluid is provided at the nutrition supply of intestinal between the trophophase, wherein, described conduit comprises the pipe in the small intestinal that is inserted into patient, described pipe defines inner chamber, be used for one or more exit openings of forming to the distal end regions at described pipe from the import transport liquid nutrition in the proximal end of described pipe, wherein, described tubing comprises pigment or dyestuff, and its outer surface at the larger proportion of pipe is provided at the purple scope or in blue spectrum or the color in green fields.
Described pipe can have single layer structure or multiple structure, for example can be formed by coextrusion.In the situation of multiple structure, the optical property of described expectation can be arranged in the described outer field material, but more preferably on the internal layer of described skin and vicinity.The skin of described nutritive canal preferably has the Shore hardness in about 40D to 70D scope, more preferably in the extremely about 60D scope of about 50D.Described skin is preferably relatively thin, and the layer of described vicinity is more soft thicker basically.
When the skin of described nutritive canal was relatively thin, preferably described skin and described internal layer were included in the pigment or the dyestuff that are fit in the described tubing.Go up in this respect, the skin of described pipe can have different tones with internal layer, so that when being combined, the outer surface of pipe has the optical property that needs.In the skin of described pipe and internal layer, provide different tones so that easier being identified of boundary between described two layers.This has again such advantage: the test of pipe in process of production and quality control (for example in the wall thickness test process by optical test) can be simplified and improve.In this, the outer field tone of the comparable described pipe of tone of internal layer is more shallow or darker.
Therefore, in aspect other, the invention provides as the conduit that is communicated with patient's small intestinal fluid is provided at the nutrition supply of intestinal between the trophophase, wherein, described conduit comprises the multilamellar pipe in the small intestinal that is inserted into patient, described pipe limits inner chamber, is used for the one or more exit openings that form to the far-end at described pipe from the import transport liquid nutrition in the proximal end of described pipe.The skin of described pipe comprises pigment or the dyestuff that the first tone is provided to described skin, and contiguous internal layer comprises pigment or the dyestuff that the second tone that is different from the first tone is provided to described internal layer.Described the second tone is preferably with in the first tone is in identical basic colors scope, and can be darker or more shallow than the first tone.
Described pipe is preferably formed by polymeric plastics material itself, and described polymeric plastics material is by selecting in the group that comprises following material: polyurethane, polyamide, polypropylene and one or more any copolymer or the block copolymer that comprises above-mentioned material.The outer surface of described pipe can also be roughened (frosted) by little coarse method ".
As already noted, the pipe of described intestinal nutrition conduit is fit to be inserted in the small intestinal by the stomach probe.For this reason, described pipe preferably has the overall diameter less than 5.0mm, more preferably less than 4.0mm, most preferably is less than or equal to 3.5mm.The inner chamber of described pipe typically has the diameter in about 1.0mm to 3.0mm scope, more preferably in about 1.5mm to 2.5mm scope.
According to a further aspect in the invention, the invention provides a kind of conduit system, comprise: the stomach probe that is used for stomach decompression or stomach fluid drainage, it comprises the pipe in the stomach that is inserted into patient, described pipe has near-end and far-end, and define inner chamber, be used for the small intestinal that reception and guiding jejunum probe are inserted into patient; With the jejunum probe that is consisted of by the conduit with above-mentioned optical property.
According to a further aspect in the invention, the invention provides a kind of being used at the nutrition supply of intestinal between the trophophase conduit that is communicated with patient's small intestinal fluid is provided, comprise the pipe that is inserted in patient's small intestinal, described pipe defines inner chamber, be used for one or more exit openings of forming to the distal end regions at pipe from the import transport liquid nutrition in the proximal end of pipe, wherein, the remote area of described pipe comprises for the device that strengthens the joint between small intestinal and described pipe.
In a preferred form of the present invention, described joint intensifier comprises the material part that is fit to absorb the intestinal fluid.Described material partly is applied on the outer surface of remote area of described pipe, and preferably has so that described material part can be from the open-celled structure of described intestinal absorption fluid.Especially, described material is the foamed polymeric material with the three dimensional structure in interconnective hole.In this, for so foamed polymeric material, the inner surface of described three-D pore structure is larger than outer surface significantly.For example, described material can have 75% voidage.Most preferably be the silicone foams of perforate, because silicone material is extremely stable in human body and can be owing to the enzyme of human body is not degraded, identical with the situation of some polyurethane foams.In addition, silicone foams is soft, and has therefore avoided the damage to the sensitive organization of intestinal.
When the remote area of described catheter tube is introduced in when being used for nutrition supply in the small intestinal, the material part with open-celled structure under the effect of infiltration and capillary force from intestinal absorption fluids.Therefore, described material partly becomes heavier and expands.Afterwards, the weight of the increase of described material part is used for the end regions of catheter tube is fixed on intestinal, and the expansion of described material part or expansion provide the friction with intestinal wall to interact.
Described material part preferably is sleeve pipe on the outer surface that is arranged on catheter tube or the form of layer.In order to locate and to fix described sleeve portion on the remote area of described pipe, the liquid that the sleeve pipe of described foamed materials can be coated with suitable (preferably volatilizable) or be immersed in the liquid of suitable (preferably volatilizable).For silicone foams, for example, the n-normal heptane may be fit to.Described sleeve portion absorbs described liquid, causes described casing expandable, so that it can easily be applied on the far-end of described catheter tube.Afterwards, described liquid is from the evaporation of described sleeve portion or vaporization, this so that described sleeve pipe be contracted on the outer surface of pipe.Described cohesive process describedly so that being contracted on the described pipe, sleeve pipe preferably described sleeve pipe is bonded to described pipe, although can utilize other binder composite or promote in conjunction with complex.
In one form, therefore, described joint intensifier is included in the elongated sleeve pipe of the foamed polymer material in the remote area of described pipe.Yet as a kind of distortion, described joint intensifier can be included on the remote area of described pipe at certain intervals a plurality of short sleeve parts of isolated foamed polymeric material.Each described short sleeve part can form the enlarged of knot shape when described conduit is placed in the described small intestinal afterwards.Namely, each sleeve portion forms local enlarged by the absorption of intestinal fluid.Described enlarged is relatively heavier, and therefore plays the effect in position of the far-end of described pipe.In addition, the expansion of described part provides the frictional engagement with the irregular surface of intestinal wall.
Therefore, in a preferred form of the present invention, the device that is used for the joint of enhancing between described small intestinal and described pipe is included at least one tuberosity configuration of the remote area of described pipe, and preferably a plurality of tuberosity configurations are spaced apart at certain intervals along the length of described remote area.Each tuberosity configuration typically comprises having diameter enlarged or the ledge larger than the overall diameter of described pipe.Therefore, described tuberosity configuration is arranged on the remote area of described pipe, is used for interacting with the wall of small intestinal.
In a specific form of the present invention, each tuberosity configuration can comprise irregular or inhomogeneous surface profile.For example, each tuberosity configuration can comprise for engaging and interactional one or more depressions and/or ledge with the irregular surface of the wall of described small intestinal.In this, each tuberosity configuration can be made of the deformation of described pipe.
In addition, the described remote area that described joint intensifier is preferably incorporated at pipe forms curling or spiral shape, so that the remote area of described pipe is biased to engage with the wall of small intestinal in use.
According on the other hand, the invention provides the method that a kind of manufacturing has the conduit of above-mentioned joint intensifier, may further comprise the steps:
The pipe that is formed by thermoplastic, polymeric materials is provided;
The one or more sleeve portions that formed by foamed polymeric material are provided;
Described sleeve portion expands;
Remote area around described pipe is placed the sleeve portion of described expansion;
Shrink the sleeve portion of described expansion to described pipe; With
In conjunction with described sleeve portion to described pipe.
In a preferred form of the present invention, the step of the described sleeve portion of described expansion comprises and applies liquid to described sleeve portion, so that described sleeve portion expands.In addition, in this preferred form of the present invention, the sleeve portion of the described expansion of described contraction to the step on the described pipe comprises from the sleeve portion of described expansion evaporates described liquid to shrink described sleeve portion to described pipe.Preferably, the step of the described sleeve portion of described contraction to the described pipe also in conjunction with described sleeve portion to described pipe.
According to another aspect of the present invention, the invention provides a kind of method of making at least the conduit with above-mentioned tuberosity configuration, said method comprising the steps of:
The pipe that is formed by thermoplastic, polymeric materials is provided;
Heat described pipe at one or more local locations, with the softening described thermoplastic polymeric material in each local position;
The pressurize inside of described pipe is so that described softening thermoplastic, polymeric materials deformation; With
In described pressurization steps, the tuberosity configuration that molded described softening thermoplastic, polymeric materials becomes to need.
In a preferred form of the present invention, the step of the inside of the described pipe of described pressurization comprises that the described pipe of connection is to the gas source of pressurization, for example air, the carbon dioxide of pressurization or the nitrogen of pressurization of pressurization.
In a preferred form of the present invention, the step of described molded described softening thermoplastic, polymeric materials be included in add depress make described material deformation in each local position in the mould of described pipe setting (for example clamping).
Therefore, in one aspect of the method, the invention provides a kind of conduit system, comprise: the stomach probe that is used for stomach decompression or stomach fluid drainage, comprise the pipe in the stomach that is inserted into patient, described pipe has near-end and far-end, and defines inner chamber, is used for receiving and guiding described jejunum probe to be inserted into patient's small intestinal; And the jejunum probe that is consisted of by the aforesaid conduit that has for the device that strengthens the joint between small intestinal and the described pipe.
With reference to the specific embodiment that shows in the accompanying drawings, invention has been described for the mode of employing example.Yet, be appreciated that description subsequently to preferred embodiment is not in order to limit aforesaid or as the versatility of inventive concept defined in the claim of enclosing.
Description of drawings
Afterwards, with reference to the accompanying drawing of enclosing the preferred embodiments of the present invention are described, wherein, same reference numbers represents identical feature, wherein:
Fig. 1 comprises the stomach probe of combination and the side view according to conduit system of the present invention of jejunum probe;
Fig. 2 is the side view of the stomach probe that shows among Fig. 1;
Fig. 3 is the schematic cross-section side view of the remote area of the stomach probe that shows in Fig. 2;
Fig. 4 is the cross section of locating at " X-X " of the stomach probe that shows among Fig. 2 according to an embodiment of the invention;
Fig. 5 has shown the details " A " of Fig. 4;
The cross section from " X-X " of the stomach probe among Fig. 6 demonstration Fig. 2 according to another embodiment of the present invention, and comprise the outstanding distortion of rib shape or the part sketch map of helical form characteristic;
Fig. 7 is the cross section of locating at " X-X " of the stomach probe that shows in Fig. 2 according to another embodiment of the invention;
Details in Fig. 8 displayed map 7 " B ";
Fig. 9 is the cross section of locating at " X-X " of the stomach probe that shows in Fig. 2 according to another embodiment of the present invention;
Figure 10 A to Figure 10 D is respectively the cross section of the Fig. 4,6 of being combined with the jejunum probe, 7 and 9 stomach probe embodiments;
Figure 11 is the side view of the jejunum probe that shows in Fig. 1;
Figure 12 is shown as the jejunum probe of Figure 11 of straightened configuration;
Figure 13 is the side view of the remote area of the jejunum probe that shows in Figure 12;
Figure 14 is presented at the curling configuration of the remote area of the jejunum probe among Figure 11;
Figure 15 is the cross section of locating at " Y-Y " of the jejunum probe that shows in Figure 11;
Figure 16 is the side view of the remote area of the pipe of jejunum probe according to an embodiment of the invention;
Figure 17 is presented at the remote area of the jejunum probe that shows among Figure 16 in further detail;
Figure 18 is the side view of remote area of the pipe of jejunum probe according to another embodiment of the present invention; With
Figure 19 is the side view of remote area of the pipe of jejunum probe according to another embodiment of the invention.
The specific embodiment
At first with reference to figure 1, shown an embodiment according to the conduit system of having assembled 10 of the present invention.Conduit system 10 comprises stomach probe 20 and jejunum probe 40, described stomach probe 20 provides with the fluid of patient's stomach and is communicated with, the decompression or the stomach fluid expulsion that are used for stomach, described jejunum probe 40 is accommodated in the stomach probe 20 and by stomach probe 20 and extends, provide with patient's small intestinal fluid to be communicated with, be used at the nutrition supply of intestinal between the trophophase.Conduit system 10 also comprises the guide wire apparatus 60 with elongated seal wire 61, and described seal wire 61 is inserted into jejunum probe 40 so that certain hardness to be provided, and is used for the small intestinal that assistance is inserted jejunum probes 40 by stomach probe 20 and is inserted into patient.With reference now to other all parts of accompanying drawing more detailed description conduit system 10.
Fig. 2 shows the total structure of stomach probe 20.In this, stomach probe 20 is the conduits that comprise the pipe 21 with near-end 22 and far-end 23.Pipe 21 is at each near-end and far- end 22,23 place's openings, and defines the single intra-cavity 24 that medially extends along its whole length between near-end and far-end.Described inner chamber 24 has two major functions.The first, be designed to provide with patient's stomach fluid be communicated with, be used for carrying out the discharge of stomach decompression and/or stomach fluid.The second, be designed to hold jejunum probe 40, be used for the small intestinal that guiding jejunum probe is inserted into patient.
The near-end 22 of stomach probe 20 is fixed (for example passing through adhesive bond) to having the roughly connecting element 25 of Y shape configuration.Described Y-connection has two ports 26,27 and is used for providing with the fluid of the inner chamber 24 of described pipe 21 and is communicated with.The first port 26 aligns with the longitudinal axis of pipe 21 usually, and described the first port 26 is designed to pass and wherein inserts the jejunum probe.Therefore, this part of Y adapter 25 is marked as " JEJUNAL (jejunum) ".This probe of Y adapter 25 inserts port 26 and also is provided with screw thread closure member 28, is used for sealing described probe and inserts port 26 when not using.
Another port that laterally arranges 27 is designed to be connected to the suction source, discharges fluid for the patient's of reducing pressure when needed stomach and/or from described stomach.This inhalation port 27 (being marked as " GASTRIC (stomach) ") is provided with wiper seal closure member 29, is used for sealing when not using described port.When described port 27 applies suction, not only by at the axially open 30 at far-end 23 places of pipe and also the collection of the lateral openings 31 that forms in by the tube wall 32 in the remote area of pipe 21 fluid is pumped in the inner chamber 24.Be clear that in the amplification diagram such as the remote area of the pipe 21 that in Fig. 3, shows that the opening 31 of these side direction is spaced apart from each other, and staggers in the opposite flank of pipe 21.In the interval S between the adjacent transverse opening 31 on the same side of pipe typically at about 30mm to about 40mm scope, the total length of remote area that is provided with the pipe 21 of these lateral openings 31 approximately is 200mm.Pipe 21 total length L own approximately are 1100mm.
In Fig. 4 to Fig. 9, shown the details according to the internal structure of the pipe 21 of the alternative embodiment of stomach probe 20.
At first with reference to figure 4, shown a specific example at the cross section of the X-X place of Fig. 2 pipe 21.Typically form described pipe 21 by extruding by the thermoplastic polyurethane material, described pipe 21 has the Shore hardness at about 50A to 80A, and the overall diameter D in about scope of 5 to 6mm oWith the interior diameter D in about 3.5 to 4.5mm scopes iRelatively soft polyurethane expects that for the damage or the injury that prevent nose, throat, esophagogastric responsive mucosa, simultaneously, in fact the size of typically being inserted the nasal cavity that passes by stomach probe 20 limits described overall diameter D between insertion and operating period o
Important characteristics of the cross section of the pipe 21 in the stomach probe of the present invention are to exist several leg-of-mutton cross sections outstanding 34, described outstanding 34 from the tube wall 32 inside outstanding inner chambers 24 that enter into.In a specific embodiments of the pipe shown in Fig. 4, stomach probe 20 have in a circumferential direction distribute equably and with about 18 ° interval independent outstanding of 20 of interval at an angle to each other.In addition, what can understand is that each that shows in Fig. 4 given prominence to 34 longitudinal extensions along pipe, in fact forms elongated rib so that each gives prominence to 34, typically follows crooked or spiral helicine path.
The more detailed view that in Fig. 5, has shown each the outstanding cross section in these rib shapes outstanding 34.Especially, can be clear that, each described rib has the cross section of general triangular, each rib reduces equably gradually with wide base regions to the relatively little round tip zone 35 of about 70 ° angle from contiguous tube wall 32 on radially inside direction, and tip region 35 extends to ridge along the length of described rib.Each tip of rib 34 or ridge form support member, and the outer surface of jejunum probe 40 can contact described support member in the insertion process of the jejunum probe of the inner chamber 24 by stomach probe 20.Because the tip of each rib shape outstanding 34 or ridge 35 have so very little circular surface zone, so describedly outstandingly in fact only carry out line with the outer surface of jejunum probe and contact.Therefore, this causes very little contact area and low-down mantle friction between jejunum probe 40 stomach function regulating probes 20.
Each rib shape outstanding 34 has the height in about 0.05mm to 0.5mm scope, is preferably about 0.2mm.This has caused representing the relative dimension D of giving prominence to the diameter between 34 pTherefore, another advantage of outstanding 34 is that they guarantee that jejunum probe 40 always keeps minimum spacing-equal height h with the inner surface of tube wall 32 at least when inserting the inner chamber 24 of stomach probe 20.In this mode, even when the outer surface of jejunum probe contacts with outstanding tip or ridge zone 35, circumference space or spacing between the outer surface of the inner surface of tube wall 32 and jejunum probe 40 are held.This prevents that the sidewise hole 31 in the remote area of pipe 21 is blocked, even by jejunum probe 40 Partial Blockings.In this mode, in fact rib shape outstanding 34 is fit to form passages (namely between the costal process of every pair of vicinity goes out), is used for transportation or is guided through stomach fluid flow that pipe 21 is drained to suction inlet 27.
20 spiral helicine rib shapes in the embodiment of Fig. 4 outstanding 34 are formed with the pitch for the circumferential span of per 1 meter about 1 inner chamber 24 of length of pipe 21.Although this provides the very configuration of expectation, but what can understand is, the pitch of these 20 spiral helicine ribs can be on per 0.3 meter length of pipe changes in the scope between the circumferential span of circumferential span inner chamber to per 3 meters length of pipe 21 of an inner chamber.
Fig. 6 shown with Fig. 4 in another similar embodiment of showing, the main difference part has just reduced by outstanding 34 number.Particularly, in the embodiment of Fig. 6, only have the outstanding length along pipe 21 of 10 elongated rib shapes to be formed, and described rib distributes equally by the circumferential area around pipe equably, this time depart from an angle to each other with about 36 ° interval.In this case, the pitch of the rib 34 of the spiral extension circumferential span of an inner chamber of per 0.5 meter length of pipe 21 typically.Fig. 6 provides around the sketch map (with dashed lines) of the route of the spiral helicine rib of pipe 21.In this, in fact each dotted line represents that the costal process of taper (diminishing gradually) goes out 34 ridge.Costal process go out 34 true form basically keep with Fig. 5 in show identical.
The present invention also designs the embodiment that the costal process that only has single distortion or spiral goes out 34 stomach probe 20.In such circumstances, described rib will desirably have the pitch of the circumferential span of an inner chamber 24 on the length of every 5mm to 20mm of pipe 21.In other limiting case, the present invention also designs has the nearly embodiment of the stomach probe 20 of 40 rib shapes outstanding 34, wherein, the pitch of each spiral helicine rib equally on per 0.3 to 3 meter length of pipe 21 in the scope of the circumferential span of an inner chamber, circumferential span on per 2 meters length of pipe preferably at this moment.
Each pipe 21 that shows in the embodiment of Fig. 4 and Fig. 6 is by making the extrusion die (not shown) in extrusion process, described mould has the round-shaped chamber that limits tube wall 32 and corresponding to the triangular shaped recess that is evenly spaced apart of outstanding 34 shape.Triangular shaped recess in described extrusion die links to each other with angled wall chamber, also can be extruded by described triangular shaped recess so that the wall by mould forms the material that the chamber is extruded, thereby produce the as a whole tube wall 32 and outstanding 34 of configuration.The outstanding triangular shaped recess of the formation of extrusion die radially inwardly is orientated to consistent with the outstanding orientation of expecting naturally.
In described extrusion process, described extrusion die typically is arranged in the extruding jet nozzle, and described extrusion die can be rotated such that extrded material produces distortion by the elongated rib shape outstanding 34 that described triangular shaped recess forms.By this way, described rib shape outstanding 34 can be longitudinally and is extended into spiral helicine form along the wall 32 of pipe 21 circumferentially afterwards.The delivery rate that is dependent on the extruding jet nozzle speed of rotation and passes through the thermoplastic of described mould, angle or the pitch of scalable helical form rib 34.Therefore, rib 34 can be limited to the spiral helicine passage between it, is used for transportation or guiding stomach fluid flow, and is emptying by described pipe.In addition, the helical form form of rib shape outstanding 34 can be suitable for when the jejunum probe is inserted into or is placed (for example when probe 40 rotation) and assists to advance described jejunum probe 40 to pass through described pipe forward.
In the extrusion process for the manufacture of described pipe 21, at least one of the processed and/or material that is colored is with 36 to be coextruded in the tube wall 32.What each was elongated is with 36 to be so-called X ray bands, and comprises radiation opaque material (for example barium sulfate), is used for seeking and visiting identification and the observation that process improves the stomach probe in the patient body in radiography (being X ray).Each also can be colored with the other parts with tubing with 36 and form contrast, is used for seeking and visiting at endoscope the visual recognition of process.For the identification of the X ray of optimum, pipe 21 preferably has around it peripheral equally spaced and be with 36 along its three of longitudinally extending, but that it can have is few to only having a band or nearly 5.
With reference now to Fig. 7 to Fig. 9,, two other embodiment of stomach probe 20 have been shown.Embodiment among Fig. 7 is giving prominence to 34 number, shape and is arranging the embodiment that describes corresponding to reference to figure 4.The main distinction of the embodiment of Fig. 7 is that the wall 32 of pipe 21 is made of two coextrusion layers, and described coextrusion layer comprises skin 37 and internal layer 38.Outer 37 material is equally preferably corresponding to the relatively soft thermoplastic polyurethane of the material among the embodiment of Fig. 4.To minimize equally the mucosa of the sensitivity that contacts with pipe 21 and the damage of tissue for the reason of the so relatively soft material in the skin.
The internal layer 38 of pipe is thin more a lot of than outer 37, and comprises outstanding 34 of configuration as a whole.Compare in about 0.5 to 0.9mm scope with outer field thickness, internal layer thickness " t " is typically in about 0.05 to 0.2mm scope.Internal layer 38 typically has the Shore hardness in 40D to 70D scope by forming than outer 37 hard a little thermoplastic polymers, more preferably is 50D to 60D.Internal layer 38 can be equally by polyurethane or for example other the thermoplastic, polymeric materials that is fit to of polyamide form.Also comprise so harder internal layer 38 of outstanding 34 help outstanding 34 and the outer surface of the jejunum probe that is inserted into of the inner chamber by stomach probe 20 between the reduction of mantle friction.Use identical configuration among the embodiment that in Fig. 9, has shown, but only difference has been to reduce costal process goes out 34 number: i.e. the elongated ribs that extend of 10 helicallies, such as the situation among the embodiment in Fig. 6, angularly around the circumference of tube wall 32 with about 36 ° spaced apart.The combination of material that is used for outer 37 softer polyurethane (PUR) and is used for the harder polyamide (PA) of internal layer 38 has been found that to producing low friction performance be especially favourable.
Figure 10 A to Figure 10 D shown with the inner chamber 24 that medially is arranged on stomach probe tube 21 in the various embodiment of stomach probe pipe 41 combinations, that describe with reference to figure 4 to Fig. 9 of jejunum probe 40.In each situation, the size of selecting stomach probe 20 and jejunum probe 40 to be providing the spacing of enough ring-type between two probes, so that decompression or the discharging optimization of the stomach in the space of the gap between the outer surface of the wall 32 by stomach probe tube 21 and jejunum probe tube 41 or ring-type.For illustrative purposes, the stomach probe tube 21 in Figure 10 A to 10D and the size of jejunum probe tube 41 are just schematic, and show that jejunum probe tube 41 medially is arranged in the stomach probe.Yet what can understand is, in use, pipe 41 can be moved on the position of off-centre of stomach probe, and contact outstanding 34.In addition, the overall diameter of jejunum probe tube 41 is comparable shown larger, so that the outer surface of pipe 41 haply more approaching outstanding 34.Yet aforesaid, outstanding 34 guarantee to keep the smallest circumference spacing between described two probes 20,40, are used for effective stomach decompression and/or discharging, namely by at each passage that forms between adjacent outstanding 34.As shown in Figure 10 A and Figure 10 B, the pipe 41 of jejunum probe 40 can have the configuration of monolayer or replacedly can have multiple structure shown in Figure 10 C and Figure 10 D, demonstrates the skin of relative thin of relatively hard materials and the thicker internal layer of softer material.
With reference to figures 11 to Figure 15 the details of jejunum probe 40 is more fully described.Jejunum probe 40 is for the conduit that is communicated with patient's small intestinal fluid is provided at the nutrition supply of intestinal between the trophophase.It comprises pipe 41, and described pipe 41 has near-end 42 and far-end 43 and defines inner chamber 44, is used for a plurality of exit openings 45 that form to the remote area in nutritive canal from the import transport liquid nutrition of near-end 42.Provide the import of inner chamber 44, described connecting element 46 (for example the passing through adhesive bond) near-end 42 to pipe 41 that is fixed by connecting element 46.Described adapter 46 is designed to threadably to be coupling in first port 26 of Y adapter 25 of stomach probe 40, after in the small intestinal that is placed on patient at the jejunum probe jejunum probe 40 is fixed in the conduit system 10.
As showing more clearly that in Figure 12 and Figure 13 exit opening 45 comprises the length l with about 3mm o4 oval-shaped openings, and be formed on separatedly on the relative sidewall of pipe 41 with the compartment of about 25mm.At far-end 43 places, described nutritive canal is provided with terminal link 46, and described member 46 typically is fixed on the pipe by adhesive bond.Described terminal link 47 has the round nose of sealing, but comprises little lateral opening, gathers or stagnates with any of liquid nutritional who prevents in the end of jejunum probe.The terminal link 47 of such sealing is as the stop of the end 62 of seal wire or stylet 61, and described seal wire is inserted in the nutritive canal 41, improves rigidity with time on the placement location that is slid to intestinal at described pipe by stomach probe 20.
Obviously, in Figure 11 and Figure 14, the distal portions of pipe 41 forms the circle of the diameter with about 30mm.Obviously, in Fig. 1 and Figure 11, the curling part of jejunum probe 40 is the distal portions that comprise the exit opening 45 of side direction.Therefore, the curling part of pipe 41 is the parts that extend to intestinal nutrition position when launching (deploy) in the small intestinal patient.Therefore, described curling zone typically has the total length l in about 200 to 300mm scopes d
Because the remote area of nutritive canal 41 is formed curling shape, before it was inserted into inner chamber 24 by stomach probe 20, it need to be stretched certainly.For this reason, adopt guide wire apparatus 60.Flexible relatively low seal wire than jejunum probe 40 is inserted in the nutritive canal 41, be inserted through stomach probe 20 at it and guided towards small intestinal before stretch described pipe.In case described nutritional probe 20 is inserted in the small intestinal, guide wire apparatus 60 is drawn back.Drawing back so that the remote area of nutritive canal 41 is tending towards being back to its curling shape of seal wire 61, this conversely the described part of bias voltage pipe engage with the wall of intestinal.This helps pipe is remained on the position that it is unfolded.
The cross-sectional configurations that in Figure 15, shows nutritive canal 41.The overall diameter d of pipe 41 oTypically in about 2.0 to 4.0mm scopes, the interior diameter d of pipe 41 i(being the diameter of inner chamber 44) is typically in about 1.0 to 3.0mm scopes.This shows the layer of two coextrusion of the pipe of describing before having shown in Figure 10 C and Figure 10 D.Outer 48 is relatively thin, has the thickness t in about 0.02mm to 0.2mm scope 1And formed by the thermoplastic, polymeric materials with the larger hardness of material (for example in about 40D to 70D Shore scope) than internal layer 49.Contrastively, the gross thickness T of wall is in about 0.4 to 0.6mm scope.Internal layer 49 forms (such as the skin of stomach probe tube 21) by the relatively soft thermoplastic, polymeric materials (for example polyurethane) that has in the Shore hardness scope of about 50A to 80A.Although can be formed by polyurethane outerly 48, for example other the material that is fit to of polyamide also can be conceived to.The advantage of this very thin skin 48 that is formed by harder polymeric material is to have reduced equally the friction between the outer surface and outstanding 34 of nutritive canal 41 during inserting jejunum probe 40.In this, it is pointed out that outstanding 34 also can be formed on the harder internal layer 38 of coextrusion stomach probe tube 21.Described very thin skin 48 provides the advantage that reduces coefficient of friction, and does not cause pipe 41 too hard or too stiff generally.
The polymeric material of nutritive canal 41 is typically formed as ray opaque, for example by adding the detectable material of radial imaging (for example barium sulfate), determines the position of probe to pass through radial imaging (that is, X-ray).In addition, in order when being thrown light on by endoscope, to improve significantly the visuality of nutritive canal, the skin of nutritive canal and internal layer are provided with pigment or dyestuff, itself so that roughly the gamut of pipe reflection have the visible light (namely in blue light range) of the wavelength in 440nm to 500nm scope, and absorb the visible light that has greater than the 500nm wavelength.Therefore, to have very large advantage be that it can be detected more easily in the video image that Application standard endoscope equipment produces to pipe 41.The such conduit that is used for intestinal nutrition is prepared by transparent polymeric material usually, and therefore extremely difficult use endoscope is visually located.Although it is tested to have the conduit of various optical properties, the jejunum probe that is designed to be reflected in the visible light in the blue light range unexpectedly is found to compare with the conduit of other type the visuality that the most significant improvement is provided.Notice that the catheter tube that has at the pigment of the indigo scope of 420nm to 440nm also can provide good result, has the catheter tube of the color that reaches green fields (for example up to 530nm) too.
Figure 16 and 17 has shown the other distortion according to jejunum probe of the present invention.These accompanying drawings have shown the remote area of nutritive canal 41, but do not have terminal link 47, and in the present embodiment, pipe 41 is included in the interior a plurality of tuberosity configurations 50 with the interval i each interval in about 30mm to 40mm scope of remote area of pipe.Comprise that the length l d of remote area of pipe 41 of tuberosity configuration 50 is roughly corresponding to the length of the crimping portion of pipe, namely approximately between 200mm to the 300mm scope.
Each tuberosity configuration 50 has irregular or inhomogeneous surface profile, and described profile roughly can be described as " wave ", and comprises zone 51 and three zones 52 that enlarge or give prominence to of two depressions.These expansions or outstanding zone 52 have the standard overall diameter d than the other parts of nutritive canal 41 oLarger overall diameter.In fact, the overall diameter of these enlarged area is typically at the overall diameter d of nutritive canal 41 o1.0 to 2.0 times of scopes in, more preferably at the overall diameter d of nutritive canal 41 o1.0 to 1.5 times of scopes in.Similarly, the zone of described depression can have the overall diameter d of nutritive canal o1.5 to 0.8 times of scopes in overall diameter.Note, if the diameter of enlarged area 52 is larger, the overall diameter d of the comparable pipe 41 of overall diameter in the zone 51 of described depression oGreatly.
Therefore, the irregular profile of each tuberosity configuration 50 provides surface or the geometric configuration that can interact and engage with the wall of small intestinal.Tube bending greatly improved the joint between pipe and the small bowel when contacting with intestinal wall when namely, the appearance of these tuberosity configurations 50 in the curling part of pipe 41 was used for removing seal wire 61.
In this, what can understand is, the wall of small intestinal is not level and smooth, but has fold or the irregular surface that outstanding (for example fine hair) from many finger-like of the mucosa of intestinal wall produces.Therefore, after removing seal wire 61, the remote area of pipe 41 is tending towards being back to its original curling shape, and described tuberosity configuration 50 contacts with the wall of small intestinal.Therefore, the inhomogeneous wavy tuberosity configuration 50 that forms in the wall of jejunal nutrient canal 41 interacts with the irregular surface of intestinal and is supported on the irregular surface of intestinal, and this helps the remote area of nutritional probe 40 is remained on the expanded position that needs.
Can make each tuberosity configuration 50 by the deformation of the thermoplastic, polymeric materials that makes pipe 41 own.In this, manufacturing typically may further comprise the steps according to the method for the jejunum probe of the embodiment of Figure 16 and 17:
At the thermoplastic, polymeric materials of the described pipe of local location heating with the softening tube wall in each position in these positions;
Arrange with at the consistent mould of the net shape of the needs of the locational tuberosity configuration 50 of each part, wherein, on the position of described part, the thermoplastic, polymeric materials of pipe is heated and is softened; With
Pipe 41 is connected to the gas source of pressurization, so that the inside of pipe is pressurized, so that softening thermoplastic, polymeric materials deformation is in the mould that each described local location is arranged, wherein, on the position of described part, described thermoplastic is softened.
In this mode, the material of pipe 41 is deflected in the mould, and the tuberosity configuration 50 that needs is provided with the local location of having selected at each.After this molding process is finished, remove the internal pressure of pipe and cool off described molded local part, so that again become firm at these locational tube materials.Therefore the tuberosity configuration 50 that needs is set in the wall of thermoplasticity pipe 41.
Figure 18 has shown another distortion according to jejunum probe of the present invention.Described accompanying drawing shows the remote area of nutritive canal 41 and does not have terminal link 47 that in the present embodiment, the remote area of pipe 41 comprises many tuberosity configurations 50 that are spaced apart from each other with the interval i in about 30mm to 40mm scope equally again.Yet in this case, each tuberosity configuration 50 comprises the columniform sleeve portion 54 of the weak point that foamed silicone material forms.The short sleeve part 54 of described foamed silicone material is bonded to the outer surface of pipe 41, and have so that sleeve portion 54 can be from intestinal the open-celled structure of draw fluid.Especially, described foamed silicone material has the three dimensional structure in interconnective hole, thereby is introduced in when being used for nutrition supply in the small intestinal under the effect of infiltration and capillary force from the intestinal absorption fluids at the remote area 41 of catheter tube.Therefore, if being placed in the small intestinal, conduit is used for intestinal nutrition, sleeve portion 54 absorption fluids, and therefore expand and become heavier.
Therefore, for the embodiment in Figure 16 and 17, silicone foams tuberosity configuration 50 has improved engaging of probe and intestinal wall.Yet in addition, the weight of the increase of the sleeve portion 54 of expansion also helps to go up in position the far-end of probe is fixing.For sleeve portion 54 is located and is fixed on the remote area of pipe, for example the suitable liquid of n-normal heptane is applied in each sleeve portion and is absorbed by each sleeve portion, thereby make its expansion (for example expanding 50%), so that it can be easy to be engaged on the far-end of pipe.Afterwards, described liquid is evaporated from sleeve portion or is vaporized, this so that sleeve pipe be contracted on the outer surface of pipe, and therefore also described both combine.
Figure 19 shows the distortion of the embodiment that shows among Figure 18, and wherein, the remote area 41 of pipe comprises single elongated skin or the sleeve portion 55 of foamed silicone material.Although present embodiment does not provide the distortion by the repetition of the overall diameter of the remote area 41 of a series of tuberosity configuration 50, but the larger length of sleeve portion 55 causes the increase of the fluid that absorbs from intestinal, thereby has produced larger weight and therefore increased fixed effect.
What can understand is, except any embodiment of foregoing description or as the interchangeable embodiment of any embodiment of foregoing description, the part of the remote extension of foamed silicone material can be connected to or be bonded to the distal tip member 47 of nutritional probe 40.The described part that is connected to the foamed silicone material of distal tip member 47 can have any suitable form, but preferably elongated.In use, when foamed silicone material described partially absorbs the intestinal fluid, it can be used as " drogue (driftanchor) " that extends from the terminal link 47 of described far-end, therefore also helps probe to be kept going up in position in its layoutprocedure.
The foregoing description of preferred embodiment of the present invention only for illustrative purposes.Therefore, be understandable that, in the situation that does not deviate from the scope of the present invention that the claim of enclosing limits, can change the particular configuration that shows in the accompanying drawing of the present invention and the layout of parts.

Claims (16)

1. a conduit (40) provides with the fluid of patient's small intestinal to be communicated with, and is used for supplying with nutrition at intestinal between the trophophase, comprising:
With the pipe (41) that is inserted in patient's small intestinal, described pipe (41) limits inner chamber (44), be used for one or more exit openings (45) of forming to the distal end regions at pipe from the import transport liquid nutrition at the near-end (42) of pipe
It is characterized in that the part of the outer surface of described pipe (41) is fit to reflection and has the visible light of the wavelength that is less than or equal to 550nm, and does not basically reflect the visible light that has greater than the wavelength of 550nm.
2. conduit according to claim 1 (40), wherein, the part of the outer surface of described pipe is greater than 40% of the external surface area of described pipe.
3. conduit according to claim 1 (40), wherein, the part of the outer surface of described pipe is greater than 60% of the external surface area of described pipe.
4. conduit according to claim 1 (40), wherein, the part of the outer surface of described pipe is greater than 80% of the external surface area of described pipe.
5. conduit according to claim 1 (40), wherein, the outer surface of described pipe (41) is fit to the visible light that reflection has the wavelength in 420nm to 520nm scope.
6. conduit according to claim 1 (40), wherein, the outer surface of described pipe (41) is fit to the visible light that reflection has the wavelength in 440nm to 500nm scope, and absorbs the visible light that has greater than the 500nm wavelength.
7. conduit according to claim 1 (40), wherein, the optical property of the outer surface of described pipe is provided by the pigment in tubing or dyestuff.
8. conduit according to claim 1 (40), wherein, described pipe has multiple structure, and the skin of described pipe has the Shore hardness in 40D to 70D scope and is formed by the material that comprises pigment or dyestuff.
9. conduit according to claim 1 (40), wherein, described pipe has multiple structure, and the Shore hardness that the outermost layer of described pipe has is greater than the Shore hardness of adjacent layer.
10. conduit according to claim 1 (40), wherein, the outer surface of described pipe is roughened by little coarse method.
11. conduit according to claim 1 (40), wherein, described pipe is fit to be inserted in the small intestinal by stomach probe (20), and has the overall diameter less than 5.0mm.
12. conduit according to claim 1 (40), wherein, described pipe is fit to be inserted in the small intestinal by stomach probe (20), and has the overall diameter less than 4.0mm.
13. conduit according to claim 1 (40), wherein, described pipe is fit to be inserted in the small intestinal by stomach probe (20), and has the overall diameter that is less than or equal to 3.5mm.
14. conduit according to claim 1 (40), wherein, the inner chamber of described pipe has the diameter in 1.0mm to 3.0mm scope.
15. conduit according to claim 1 (40), wherein, the inner chamber of described pipe has the diameter in 1.5mm to 2.5mm scope.
16. conduit according to claim 1 (40), wherein, described pipe is formed by polymeric plastics material, and described polymeric plastics material is to select from the group that comprises following material: polyurethane, polyamide, polypropylene and one or more any copolymer or the block copolymer that comprises above-mentioned material.
CN2007800388513A 2006-10-20 2007-10-18 Catheter system Active CN101534784B (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP06022077.9 2006-10-20
EP06022077A EP1913926B1 (en) 2006-10-20 2006-10-20 Catheter system
PCT/EP2007/009064 WO2008046636A2 (en) 2006-10-20 2007-10-18 Catheter system

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CN101534784A CN101534784A (en) 2009-09-16
CN101534784B true CN101534784B (en) 2013-01-02

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CN (1) CN101534784B (en)
AT (2) ATE491430T1 (en)
AU (1) AU2007312525A1 (en)
BR (1) BRPI0717973B8 (en)
DE (2) DE602006018949D1 (en)
ES (2) ES2354903T3 (en)
NZ (1) NZ575875A (en)
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Publication number Publication date
ES2342336T3 (en) 2010-07-05
RU2445069C2 (en) 2012-03-20
ATE466561T1 (en) 2010-05-15
US8603065B2 (en) 2013-12-10
BRPI0717973B1 (en) 2018-12-18
EP1913926A1 (en) 2008-04-23
DE602007006331D1 (en) 2010-06-17
WO2008046636A2 (en) 2008-04-24
CN101534784A (en) 2009-09-16
ATE491430T1 (en) 2011-01-15
DE602006018949D1 (en) 2011-01-27
US20100298812A1 (en) 2010-11-25
WO2008046636A3 (en) 2008-06-19
EP2076232B1 (en) 2010-05-05
ES2354903T3 (en) 2011-03-21
NZ575875A (en) 2012-06-29
EP1913926B1 (en) 2010-12-15
EP2076232A2 (en) 2009-07-08
RU2009117641A (en) 2010-11-27
AU2007312525A1 (en) 2008-04-24
BRPI0717973A2 (en) 2013-11-05
BRPI0717973B8 (en) 2021-06-22

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